Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05198791

The Effect of Mineralocorticoid Receptor Antagonist Therapy in Patients With Acute Myocardial Infection or Injury and no Obstructive Coronary Arteries: a Registry-based, Stratified-medicine, Randomized, Controlled Trial

Led by NHS National Waiting Times Centre Board · Updated on 2026-03-16

400

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

N

NHS National Waiting Times Centre Board

Lead Sponsor

B

British Heart Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of eplerenone, a drug that blocks mineralocorticoid receptors, in patients who have had a heart attack or heart injury but do not have blocked large coronary arteries. The study focuses on patients with problems in small blood vessels in the heart, known as coronary microvascular dysfunction. The goal is to see if eplerenone can reduce heart damage and improve heart function in this group, as well as to better understand this condition using advanced tests and imaging. The trial includes a registry-based diagnostic study and a nested randomized, open-label, blinded-endpoint trial. Patients admitted with suspected heart attack undergo angiograms to assess small vessel function using a special guidewire. Those with coronary microvascular dysfunction (measured by an index of microvascular resistance (IMR) ≥ 25) are randomly assigned to receive either eplerenone tablets, starting at 25 mg daily and increased to 50 mg after two weeks for six months, or standard care without eplerenone. Patients without microvascular dysfunction enter a registry for follow-up. Additional imaging including heart MRI and brain MRI substudies are performed. Participants will be closely monitored during hospital stays and through follow-up visits at one and six months, involving blood tests, heart MRI scans, and questionnaires assessing health status and quality of life. Long-term health outcomes such as hospitalizations and survival will be tracked via electronic records for up to 20 years. The main outcome measured is the change in heart injury biomarkers (NT-proBNP) over six months, alongside assessments of heart function, patient well-being, and other cardiovascular events.

CONDITIONS

Brief Title

Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Acute myocardial infarction or myocardial injury without obstructive coronary arteries
  • At least one cardiovascular risk factor such as age over 70, atrial fibrillation, diabetes, current smoking, moderate kidney impairment, prior heart attack, treated hypertension, or COVID-19
  • Undergoing coronary angiography
Not Eligible

You will not qualify if you...

  • Obstructive coronary artery disease
  • Left ventricular ejection fraction 40% or less with heart failure after myocardial infarction
  • Severe kidney impairment (eGFR less than 30 mL/min/1.73 m2)
  • Severe liver impairment
  • Women who are pregnant, breastfeeding, or of childbearing potential without negative pregnancy test and not using effective contraception
  • Current use of mineralocorticoid receptor antagonists
  • Taking certain antifungal, antiviral, antibiotic, or antidepressant medications
  • Use of both an ACE inhibitor and an angiotensin receptor blocker together
  • Contraindications to MRI or intravenous adenosine
  • Lack of informed consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit during coronary angiography

Treatment

Duration - 6 months

Participants with increased microvascular resistance (IMR ≥25) are randomized to receive eplerenone tablets daily for six months or standard care without eplerenone.

Visits at enrollment, 30 days, and 6 months

Follow-up

Duration - Up to 20 years

Participants are monitored through registry follow-up including electronic health record linkage for up to 20 years to assess long-term outcomes and medication use.

Periodic follow-up visits and health record assessments

Trial Site Locations

Total: 2 locations

1

University Hospital Hairmyres

East Kilbride, Lanarkshire, United Kingdom, G75 8RG

Actively Recruiting

2

Golden Jubilee National Hospital

Glasgow, United Kingdom

Actively Recruiting

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Research Team

C

Colin Berry, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

The role of a comprehensive two-step diagnostic evaluation to unravel the pathophysiology of MINOCA: A review.

Francesco Pelliccia, Carl J Pepine, Colin Berry...

https://pubmed.ncbi.nlm.nih.gov/34087335